Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.

Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.

The PATHWAYS intervention is a psychoeducational intervention comprised of three components.

PATHWAYS

The enhanced usual care condition consists of an information resource guide.

Enhanced usual care

Kelsey Lau-Min, MD, MSCE

The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).

This is a randomized control trial that will be split into two phases. Study Phase I will test the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants.

In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online).

It is expected that about 120 people will take part in this research study.

Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).

An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

PATHWAYS: An Informational and Supportive Care Intervention to Enhance Self-Efficacy for Patients With Locally Advanced Rectal Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary outcome for Study Phase I will be feasibility, defined as ≥60% retention of participants over the four-week intervention.

The primary outcome for Study Phase II will be self-efficacy, assessed using the Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE-Cancer). CASE-Cancer scores range from 12-48, with higher scores indicating greater self-efficacy.

The secondary outcome for Study Phase II will be acceptability of the intervention, defined as ≥80% of participants reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).

A secondary outcome for Study Phase II will be a different measure of self-efficacy, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Measures for Managing Chronic Conditions. PROMIS scores range from 8-40, with higher scores indicating greater self-efficacy.

A secondary outcome for Study Phase II will be coping, assessed using the Brief Cope (B-COPE). B-COPE scores range from 28-112, with higher scores indicating greater coping ability.

A secondary outcome for Study Phase II will be resilience, assessed using the Brief Resilience Scale (BRS). BRS scores range from 6-30, with higher scores indicating greater resilience.

A secondary outcome for Study Phase II will be social isolation, assessed using the Patient-Reported Outcomes Measurement Information System Social Isolation (PROMIS SI). PROMIS SI scores range from 4-20, with higher scores indicating greater social isolation.

A secondary outcome for Study Phase II will be decisional regret, assessed using the Decision Regret Scale (DRS). DRS scores range from 5-25, with higher scores indicating greater decisional regret.

Assessed using the Edmonton Symptom Assessment Scale (ESAS). ESAS scores range from 0-90, with higher scores indicating greater symptom burden.

A secondary outcome for Study Phase II will be psychological distress, assessed using the Patient Health Questionnaire (PHQ-4). ESAS scores range from 0-12, with higher scores indicating greater psychological distress.

A secondary outcome for Study Phase II will be quality of life, assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C). FACT-C scores range from 0-136, with higher scores indicating greater quality of life.

Massachusetts General Hospital

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Etoposide phosphate

preoperative radiochemotherapy

Michael Thomas, Prof. / MD

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

University Hospital Muenster

Lung Clinic Hemer

Kreiskrankenhaus Diekholzen

University Hospital, Saarland

FLT Berlin / Buch

Heidelberg University

Enzyme Inhibitors

Surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. Cisplatin 50 mg/M\^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.

Etoposide given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. Prophylactic Cranial Irradiation 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.

Segmentectomy or lobectomy with en bloc resection of the involved chest.

Surgery

Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.

Chest Irradiation

50 mg/M\^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.

given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.

25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.

Prophylactic Cranial Irradiation

Ritsuko Komaki, MD

1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy.

Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29.

If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.

Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

Locoregional control (LRC) defined as disease non-recurrence in a localized area for patients with resectable superior sulcus tumors treated with surgical resection followed by adjuvant chemoradiation. LRC measured as percentage of participants without recurrence at rates of local control as measured Years 2, 5, and 10.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer	NCT05914766	Rectal Cancer Self Efficacy	PATHWAYS Enhanced usual ...	18 Years -	Massachusetts General Hospital
Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)	NCT00176137	Non-Small Cell ...	preoperative ra...	18 Years - 69 Years	Heidelberg University
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors	NCT00984997	Lung Cancer	Surgery Chest Irradiati... Cisplatin Etoposide Prophylactic Cr...	18 Years - 70 Years	M.D. Anderson Cancer Center
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors	NCT00984997	Lung Cancer	Surgery Chest Irradiati... Cisplatin Etoposide Prophylactic Cr...	18 Years - 70 Years	M.D. Anderson Cancer Center

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