RACE-trial: Neoadjuvant Radiochemotherapy versus Chemotherapy for Patients with Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A randomized phase III joint study of the AIO, ARO and DGAV

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitat Heidelberg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Jun 2020 → ongoing

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Stiftung Deutsche Krebshilfe

External identifiers

EU CT number

2024-516271-32-00

EudraCT number

2018-001728-20

ClinicalTrials.gov

NCT04375605

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The primary endpoint of the study is to investigate whether the addition of preoperative radiochemotherapy is superior to perioperative chemotherapy alone in the treatment of resectable GEJ adenocarcinoma by improving progression-free survival in patients undergoing oncologically adequate surgery (D2 resection and appropriate mediastinal lymphadenectomy).

Conditions and MedDRA coding

Adenocarcinoma of the gastroesophageal junction (AEG type I-III)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, or cT2 N+ M0 according to AJCC 8th edition
2. 2. Patients* must be candidates for potential curative resection as determined by the treating surgeon.
3. 3. ECOG performance status 0-1
4. 4. Age 18 years or above
5. 5. Adequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l and hemoglobin ≥ 9.0 mg/dl
6. 6. INR <1.5 and aPTT<1.5 x upper limit of normal (ULN) within 7 days prior to randomization
7. 7. Adequate liver function as measured by serum transaminases (ASAT, ALAT) ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN
8. 8. Adequate renal function with serum creatinine ≤ 1.5 x ULN
9. 9. QTc interval (Bazett**) ≤ 440 ms
10. 10. Written informed consent obtained before randomization
11. 11. Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective contraceptive measures*** during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.

Exclusion criteria 14

1. 1. Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs])
2. 2. Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
3. 3. Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03 (see appendix)
4. 4. Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
5. 5. Pregnant or lactating females
6. 6. Patients medically unfit for chemotherapy and radiotherapy
7. 7. Patients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted
8. 8. Known hypersensitivity against 5-FU, folinic acid, oxaliplatin or docetaxel
9. 9. Other known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel
10. 10. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
11. 11. Clinically significant valvular defect
12. 12. Other severe internal disease or acute infection
13. 13. Peripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03
14. 14. Chronic inflammatory bowel disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS)

Secondary endpoints 7

1. Overall survival, including survival rates after 1, 3 and 5 years
2. R0 resection rate
3. Number of harvested lymph nodes
4. Site of tumor relapse
5. Perioperative morbidity and mortality rate
6. Safety and toxicity as assessed by NCI CTC criteria
7. Quality of life by using the EORTC QLQ-C30 and the esophagogastric module OG25

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitat Heidelberg

Sponsor organisation

Universitat Heidelberg

Address

Seminarstrasse 2, Altstadt Altstadt

City

Heidelberg

Postcode

69117

Country

Germany

Scientific contact point

Organisation

Universitat Heidelberg

Contact name

Ralf Hofheinz

Public contact point

Organisation

Universitat Heidelberg

Contact name

Ralf Hofheinz

Locations

1 EU/EEA country · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications