Role of metronomic schedule of Oral Capecitabine therapy in improving performance status of advanced or metastatic Gastrointestinal cancers.

Role of oral metronomic chemotherapy with best supportive care vs. best supportive care among treatment naive advanced and/or metastatic Gastrointestinal cancers patients with KPS 30-60 - RoMe GI 30-60

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084696

Enrollment

Registered

2025-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: C169- Malignant neoplasm of stomach, unspecified Health Condition 2: C179- Malignant neoplasm of small intestine, unspecified Health Condition 3: C189- Malignant neoplasm of colon, unspecified Health Condition 4: C20- Malignant neoplasm of rectum Health Condition 5: C210- Malignant neoplasm of anus, unspecified Health Condition 6: C23- Malignant neoplasm of gallbladder Health Condition 7: C259- Malignant neoplasm of pancreas, unspecified Health Condition 8: C260- Malignant ne

Interventions

Intervention1: Oral metronomic therapy with best supportive care: Tablet Capecitabine 500 mg per oral twice daily for 21 days, for upto 12 weeks with best supportive care as per institutional policy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. Histology-proven adenocarcinoma of the Gastrointestinal tract (all sub-sites). 3. Karnofsky Performance Score between 30 to 60. 4. No previous exposure to chemotherapy

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with KPS below 30 and above 60. Patients with abnormal liver function (total bilirubin more than 3 times upper normal limit (UNL), AST and ALT more than 3 times in the absence of liver metastasis or more than 5 times in the presence of liver metastasis) Patients with abnormal Kidney function with creatinine clearance of less than 30 ml/min/ 1.73 m2 BSA with cockrauft gault formula. Pregnant and lactating females Children below 18 years of age. Brain metastasis Patient with hemodynamic instability. Patient with active infection or sepsis New York Heart Association grade III or IV congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry. Any acquired immunodeficiency state

Design outcomes

Primary

Measure	Time frame
Conversion rate (%)Timepoint: Conversion rate (%) 12 weeks	—

Secondary

Measure	Time frame
1. Symptom control in terms of change in 13-Items Symptom Distress Score (SDS) at the end of 12 weeks in two study groups. 2. Pain control in terms of change in Numerical rating scale (NRS) score at the end of 12 weeks in two study groups. 3. Quality of life (QoL) in terms of change in Functional Assessment of Cancer Therapy-General 7 score (FACT G7) at the end of 12 weeks in two study groups. 4. Adverse events/ toxicity of respective intervention during and end of 12 weeks in two study groups using Common Terminology Criteria For Adverse Event-Us Department Of Health And Human Services National Cancer Institute. (CTCAE 5.0) Timepoint: 12 weeks	—

Measure

Time frame

1. Symptom control in terms of change in 13-Items Symptom Distress Score (SDS) at the end of 12 weeks in two study groups. 2. Pain control in terms of change in Numerical rating scale (NRS) score at the end of 12 weeks in two study groups. 3. Quality of life (QoL) in terms of change in Functional Assessment of Cancer Therapy-General 7 score (FACT G7) at the end of 12 weeks in two study groups. 4. Adverse events/ toxicity of respective intervention during and end of 12 weeks in two study groups using Common Terminology Criteria For Adverse Event-Us Department Of Health And Human Services National Cancer Institute. (CTCAE 5.0) Timepoint: 12 weeks

—

Countries

India

Contacts

Public ContactDr. Parmod Kumar

All India Institute of Medical Sciences, Jodhpur

parmodkpal@gmail.com9810200367

Outcome results

None listed

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