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Therapy for Cancer at Stomach and Esophagous junction

Neoadjuvant Chemotherapy vs Neoadjuvant Chemoradiotherapy for Resectable Carcinoma Gastroesophageal junction : a Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013757
Enrollment
50
Registered
2018-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with resectable Carcinoma Gastroesophageal junction without clinical metastasis

Interventions

Intervention1: DCF ( Docetaxel
5- Flurouracil) based chemotherapy regimen: 3 cycles of DCF ( Docetaxel
5- Flurouracil) based chemotherapy regimen before surgery and 3 more cycles in adjuvant setting. surgery will be performed after 6 weeks from first 3 cycles.Common Terminology criteria for Adverse eve
5-Flurouracil weekly with Radiotherapy (50.4 Gy in 28 fraction): Chemotherapy will constitute cisplatin
5-Flurouracil weekly concurrently with with Radiotherapy (50.4 Gy in 28 fractions) followed by surgery after 6 weeks. Common Terminology criteria for Adverse events (CTCAE) will be used to measure tox

Sponsors

Dr Shivendra Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with resectable and hitologically proven adenocarcinoma of Gastroesophageal junction(type I,II,III) who are fit for surgery(ECOG performance status 0,1,2); No Distant metastasis on PET scan and Staging Laparoscopy

Exclusion criteria

Exclusion criteria: Distant metastasis on Staging Laparoscopy or on PET scan; refusal for informed consent for procedure; locally unresectable tumors; tumors falling in stage cT1N0 on Endoscopic ultrasound examination

Design outcomes

Primary

MeasureTime frame
Comparison of median survival rates in patient treated with NACT followed by surgery with NACTRT followed by surgeryTimepoint: 30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years

Secondary

MeasureTime frame
Pathological response; Progression free survival; number of R0 resections; treatment toxicity; quality of lifeTimepoint: 30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years

Countries

India

Contacts

Public ContactDr Shivendra Singh

Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 North West DELHI 110085

singh.shivendra@rgcirc.org9818975024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026